PRIMO
Received Dec 17, 2025 · Event occurred Aug 21, 2024
Report 3004824601-2025-00190 · MDR key 23828866
Device
Generic name
Heel Offloading Boot
Model number
HC1WProduct problems
- Inadequate or Insufficient Training
- Inadequate or Insufficient Training
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
ON (B)(6) 2024, CUSTOMER REPORTED THAT HC1W HEELCHECK BOOT, STANDARD W/WEDGE WAS NOT PROPERLY BEING USED BY HOSPITAL STAFF. AS A RESULT, 18 HOSPITAL-ACQUIRED PRESSURE INJURIES WERE OBSERVED.
Additional Manufacturer Narrative
THESE MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED PAST THE REGULATORY REPORTING TIMEFRAME AS THEY ARE A RESULT OF A RETROSPECTIVE REVIEW OF OUR COMPLAINTS. THE EVENT WAS EVALUATED AND DETERMINED NOT TO INVOLVE A DEVICE MALFUNCTION; THE ROOT CAUSE WAS IDENTIFIED AS A USE ERROR. HOWEVER, GIVEN THAT A MINOR INJURY WAS REPORTED, THE EVENT IS BEING REPORTED IN LINE WITH APPLICABLE VIGILANCE REPORTING REQUIREMENTS.